Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives (PILL-OFF)

May 20, 2021 updated by: Marc Blondon, University Hospital, Geneva

Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives: a Prospective Cohort Study

This prospective cohort evaluates the longitudinal profile of hemostatic biomarkers during the first 3 months after having stopped a combined oral contraceptive.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women using a combined oral contraceptive (COC) and who have decided to stop it or switch it to a non-estrogenic contraceptive are included. At baseline, before the COC is stopped, and at multiple time points during the 3 months of follow-up, blood will be drawn to evaluate the hemostatic profile. Findings are compared with a control group of women without an estrogenic contraceptive, who are also followed for 3 months.

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women aged 18-50 years who are current users of estrogenic contraceptives and have decided to stop it or replace it with a non-estrogenic contraceptive.

Women aged 18-50 years who are not current users of estrogenic contraceptives.

Description

Inclusion Criteria:

  • women
  • 18-50 years
  • current use (for at least 3 months) of an estrogenic contraceptive with the decision to stop it or replace it with a non-estrogenic contraceptive (estrogen group)
  • no current use of an estrogenic contraceptive (control group)

Exclusion Criteria:

  • personal history of VTE
  • known thrombophilia
  • recent medical event (hospitalization, surgery, cancer)
  • pregnancy, post-partum period, current breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Estrogenic contraceptive users
Other: Tests of biological hemostatic profile associated with contraceptives
Tests of biological hemostatic profile associated with contraceptives will be done before and after having stopped an estrogenic contraceptive (group 1) and during the non-use of an estrogenic contraceptive (group 2)
Non-estrogenic contraceptive users
Other: Tests of biological hemostatic profile associated with contraceptives
Tests of biological hemostatic profile associated with contraceptives will be done before and after having stopped an estrogenic contraceptive (group 1) and during the non-use of an estrogenic contraceptive (group 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in normalized APC sensitivity ratio
Time Frame: Three months
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Endogenous Thrombin Potential (Thrombin Generation Assay)
Time Frame: Three months
Three months
Change in concentrations of sex hormone-binding globulin
Time Frame: Three months
Three months
Change in fibrinolysis assay
Time Frame: Three months
Three months
Change in individual coagulation factors
Time Frame: Three months
The following coagulation factors will be assessed: fibrinogen, protein C, protein S, antithrombin, factor VIII
Three months
Contraception-related satisfaction
Time Frame: Three months
Satisfaction will be estimated by the use of the Ortho Birth Control Satisfaction Assessment Tool questionnaire.
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 8, 2018

Primary Completion (ACTUAL)

September 14, 2020

Study Completion (ACTUAL)

September 14, 2020

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (ACTUAL)

May 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-00448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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